W-12: The Clinical Development Design (CDD) Framework: Assisting and Improving Decision-Making for Product Development

Poster Presenter

Mary Banach

Clinical Data Educator
VUMC
United States

Objectives

To explore structured criteria using design principles and the tracking of decisions during medical product development programs in order to achieve an understanding of the impact of the major factors affecting decision-making and the improvement in such decision-making in future.

Method

We identified product development key decision points and extracted terms to establish a Clinical Development Design (CDD) Framework ontology. This Information Model integrates decision points with data from 3 databases, eCTD, Risk Review, and Design Structure, to make generic concept maps (Cmaps).

Results

The generic Cmaps provide a framework to capture, modify, and link the key process flow and decision elements for the clinical development of a medical product from inception to post marketing surveillance. The interactions at each step, the drivers, and the manifestations of changing input, decision results, and downstream effects can be viewed retrospectively, modeled prospectively, and used to analyze projects on a comparable basis, independent of product type or therapeutic area. Through the ontology-based Cmaps, resource planning and quality assurance can gain greater precision and reproducibility. Regulatory strategy, knowledge gaps, and other options can be identified and optimized while accounting for relevant factors.

Conclusion

The CDD Framework, ontology, and Cmaps offer stakeholders in clinical research an opportunity to view the decisions made from the original clinical research question to post-marketing surveillance and the impact of various factors on decision, data, and business outcomes. The Cmaps are part of a learning system that can accommodate new methods, guidance documents, formats, concepts, and terms through the structure of the CDD ontology and integrate information from linked databases. The Cmaps allow identification and tracking of the key enabling information that supports or leads to specific decisions and outcomes.